A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)

A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate the Effects of Multiple Oral Doses of 2000 mg of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity in Subjects With Hypercholesterolemia

A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: Niaspan; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Female subjects of reproductive potential test negative for pregnancy and agree to use appropriate methods of contraception throughout the study
• Subject is in good health (other than history of high cholesterol)
• Subject is a non-smoker

Exclusion Criteria:

• Subject has a history of stroke, seizures or major neurological disorder
• Subject has a history of cancer
• Subject is unable to refrain from or anticipates the use any prescription or non-prescription drugs
• Subjects consumes excessive amounts of alcohol or caffeine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Niaspan - Placebo	Drug: Niaspan; Oral doses of 2000 mg of Niaspan once daily for 7 days.; Drug: Comparator: Placebo; Oral doses of placebo once daily for 7 days.
Experimental: 2; Placebo - Niaspan	Drug: Niaspan; Oral doses of 2000 mg of Niaspan once daily for 7 days.; Drug: Comparator: Placebo; Oral doses of placebo once daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
flow-mediated dilation (FMD) of brachial artery	predose, 4 hours post dose and 24 and hours post dose
Nitroglycerin (GTN) induced dilation of brachial artery	predose, 4 hours post dose and 24 hours post dose

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: April 13, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 15, 2010

Study Record Updates

• Last Update Posted (Estimate): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Antimetabolites; Micronutrients; Hypolipidemic Agents; Lipid Regulating Agents; Vitamins; Vitamin B Complex; Nicotinic Acids; Niacin
• Other Study ID Numbers: 0000-093; 093; 2010_524